Skip to content

Oralieve Spray 50mL

by Europharma Concepts Ltd Ireland EUDAMED

Ref 61ORSP50A EMDN V9017

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-61ORSP50AZC Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Oralieve Spray 50mL
Model / Reference
61ORSP50A
Primary DI / UDI-DI
D-61ORSP50AZC
Basic UDI-DI
B-61ORSP50AZC
EMDN Code
V9017 Oral administration preparations not included in other classes
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000024843

Other devices from Europharma Concepts Ltd

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED a72ee8a0-30a1-4272-921a-ca59156aee1a 61 fields · synced 22 Oct 2026